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New treatment option for Asthma
Official title Viral Mucosal Reprogramming
ClinicalTrials.gov ID: NCT05331170
What this study is testing
What is Research Grade RG-RV?
Research Grade RG-RV is an investigational medicine, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a mechanistic, controlled, open-label, single-site study to evaluate the effects of RG-RV16 inoculation on airway mucosal gene expression and airway remodeling in 25 healthy controls (HC), in 25 allergic rhinitis subjects (AR) with cat dander allergy, and in 25 allergic asthmatic subjects (AA) with cat dander allergy. Three groups (HC, AR, and AA) will undergo screening to establish clinical history, will undergo pulmonary function testing (spirometry), and will have blood drawn for clinical characterization (IgE, , ImmunoCAP, CBC and differential), and for assessing the presence of existing neutralizing antibody against RV16.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Healthy Normal Control Group
- Subject must be able to understand and provide informed consent
- Age: 18-60 inclusive
- Sex: M or F
- No history of asthma, COPD, rhinitis, or other clinically important respiratory disease
You likely can't join if
- Healthy Group Normal Group
- Inability or unwillingness of a participant to comply with study protocol
- Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease.
- Neutralizing Ab to RV16 greater than or equal to 1:8
- Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative...
- people with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic...
See the full eligibility criteria
Who can join
- Healthy Normal Control Group
- Subject must be able to understand and provide informed consent
- Age: 18-60 inclusive
- Sex: M or F
- No history of asthma, COPD, rhinitis, or other clinically important respiratory disease
- Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote.
- No history of diabetes or cardiovascular disease
- Negative ImmunoCAP test to regionally relevant allergen panel obtained at Screening. Alternatively, documented history of a negative skin test or negative specific IgE obtained within the past 12 months. Allergic...
- Subject must be able to understand and provide informed consent
- Age: 18-60 inclusive
- Sex: M or F
- No history of asthma, COPD, or other clinically important respiratory disease
- Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote
- No history of diabetes or cardiovascular disease
- History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months
- Seasonal or perennial nasal congestion or sneezing
- Seasonal or perennial conjunctival infection or watering
- No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal)
- Positive ImmunoCAP test to cat. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criterion. people must have cat in home, have regular exposure...
- Subject must be able to understand and provide informed consent
- Age: 18-60 inclusive
- Sex: M or F
- No history of COPD or other clinically important respiratory disease other than asthma
- Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote
- No history of diabetes or cardiovascular disease
- History of mild-moderate asthma, physician diagnosed, plus one of the following criteria within the past 12 months
- Airway obstruction (FEV1: FVC \<0.6) that is significantly (at least 12% change from baseline, ATS criteria) reversible after 4 puffs of albuterol (obtained at Screening Visit or documented historical testing performed...
- Requiring ICS for control of asthma for at least 30 days within the past 12 months
- Positive ImmunoCAP test to cat dander. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criteria. people must have cat in home, have regular...
- Results of the CBC do not show clinically important abnormalities
What rules you out
- Healthy Group Normal Group
- Inability or unwillingness of a participant to comply with study protocol
- Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease.
- Neutralizing Ab to RV16 greater than or equal to 1:8
- Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at the screening visit. Pregnancy testing may be conducted...
- people with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are...
- people who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver). Allergic Rhinitis Group
- Inability or unwillingness of a participant to comply with study protocol
- Currently using inhaled steroids, or oral montelukast for respiratory disease
- Neutralizing Ab to RV16 greater than or equal to 1:8
- Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at screening visit. Pregnancy testing may be conducted...
- people with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are...
- people who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
- people who have received immunosuppressive treatment within the last 12 months
- BMI is greater than 35
- History of symptoms consistent with a viral URI within the past 21 days
- Results of the CBC do not show clinically important abnormalities
- Family history or medical history of liver disease or bleeding disorders
- Have not received systemic corticosteroids for 3months prior to Screening
- Antiplatelet agents other than aspirin
- people who have a positive COVID-19 test will be excluded for 8 weeks Allergic Asthma Group
- Inability or unwillingness of a participant to comply with study protocol
- Currently taking medications for respiratory diseases other than ICS, montelukast, or rescue albuterol or LABAs.
- Neutralizing Ab to RV16 greater than or equal to 1:8
- FEV1: FVC ratio less than 0.6, or FEV1 less than 60% predicted
- Recent (\<30 days) exacerbation of asthma requiring systemic corticosteroids
- ICS greater than fluticasone 500 mcg/day or its equivalent (GINA 2019 table) at screening.
- Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at screening. Pregnancy testing may be conducted prior to...
- people with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are...
- people who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
- people who have received immunosuppressive treatment within the last 12 months
- BMI is greater than 35
- History of symptoms consistent with a viral URI within the past 21 days
- Family history or medical history of liver disease or bleeding disorders
- Have not received systemic corticosteroids for 3 months prior to Screening
- Have an ACT score \>19 at the time of enrollment.
- Antiplatelet agents other than aspirin
- people who have a positive COVID-19 test will be excluded for 8 weeks
The study team makes the final eligibility decision.
Where it's taking place
- Galveston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.